Guideline for Industry e-reporting

This document serves as a guideline for those reporting adverse drug reactions. It represents the South African Health Products Regulatory Authority’s (SAHPRA)’s current thinking on the safety, quality and efficacy of medicines. The Authority reserves the right to request any additional information to establish the safety, quality and efficacy of a medicine and may make amendments to the approved conditions of registration in keeping with the knowledge which is current at the time of consideration of safety data.